Pathos AI
Director / Senior Director of Regulatory Affairs
New York City, NY · Director
Sponsorship not specifiedDetected 158 days ago
Machine LearningAgentic AIFDA RegulatoryLeadershipCollaborationBiostatisticsRegulatory Affairs
About the role
- You will be the person FDA knows and the person accountable for every submission that leaves Pathos.
- What makes this role different is how the work gets done.
- You will direct AI agents to handle the execution layer of regulatory tasks, apply your expert judgment to review and finalize outputs, and work with our engineering teams to make those systems more capable over time.
Responsibilities
- IND Lifecycle Management Own the full IND lifecycle for Pathos's oncology pipeline.
- Build and maintain the SOPs, controlled document systems, and records management infrastructure that support a growing pipeline.
- Direct AI agents to generate first drafts of regulatory documents, flag inconsistencies, and surface relevant precedent.
- Lead preparation of pre-IND meeting requests, Type B and Type C meeting packages, and End of Phase meetings.
- Engage proactively and frequently with FDA, particularly around Pathos's AI-enabled development model and novel trial designs.
Compensation
- Author and submit IND amendments, prepare annual reports, lead DSUR development in collaboration with safety, biostatistics, and data management, and maintain IB currency across all active studies.
Benefits
- Agentic Regulatory Workflows Work with Pathos's software and machine learning engineering teams to build AI-powered systems that accelerate regulatory execution.
Visa & Work Authorization
- FDA Relationship Serve as Pathos's primary sponsor representative with FDA across all active programs
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This listing is sourced directly from Pathos AI's careers page and normalized into a canonical job model.